Acceptance and Commitment Therapy for Patients With Chronic Heart Failure and Their Caregivers on Their Quality of Life

NCT04917159 | Completed DMC

• 1 other identifier: PU001
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to examine whether group-based Acceptance and Commitment Therapy in the patient-caregiver dyads with Chronic Heart Failure is effective in improving dyadic health-related quality of life, dyadic psychological symptoms, caregiver burden, the rate of patient's readmission, and patient's self-care behavior in comparison with those dyads receiving health education over three-month post intervention.

Conditions

Chronic Heart Failure

Keywords

Chronic heart failure; Acceptance and Commitment Therapy; Patient-caregiver dyads; Health-related quality of life; Randomized controlled trial

Outcome Measures

Primary Outcomes (6)

• Change from baseline in patients' CHF specific health-related quality of life at immediately post-intervention

  The short-form Kansas City Cardiomyopathy Questionnaire (KCCQ-12) will be used for patients. KCCQ-12 is a 12-item instrument with a score of 0-100, a lower score indicates a poorer quality of life.

  Baseline and post-intervention immediately

• Change from baseline in patients' CHF specific health-related quality of life at 3-month post-intervention

  The short-form Kansas City Cardiomyopathy Questionnaire (KCCQ-12) will be used for patients. KCCQ-12 is a 12-item instrument with a score of 0-100, a lower score indicates a poorer quality of life.

  Baseline and three-month post-intervention

• Change from baseline in patients' generic health-related quality of life at immediately post-intervention

  The five-dimensional descriptive system of the EuroQol Group 5-Dimension questionnaire (EQ-5D-5L) will be used to evaluate generic health-related quality of life for patients. The scores range from less than 0 to 1.0, with higher scores representing higher health utility.

  Baseline and post-intervention immediately

• Change from baseline in patients' generic health-related quality of life at three-month post-intervention

  The five-dimensional descriptive system of the EuroQol Group 5-Dimension questionnaire (EQ-5D-5L) will be used to evaluate generic health-related quality of life for patients. The scores range from less than 0 to 1.0, with higher scores representing higher health utility.

  Baseline and three-month post-intervention

• Change from baseline in caregivers' health-related quality of life at immediately post-intervention

  The five-dimensional descriptive system of the EuroQol Group 5-Dimension questionnaire (EQ-5D-5L) will be used to evaluate generic health-related quality of life for caregivers. The scores range from less than 0 to 1.0, with higher scores representing higher health utility.

  Baseline and post-intervention immediately

• Change from baseline in caregivers' health-related quality of life at three-month post-intervention

  The five-dimensional descriptive system of the EuroQol Group 5-Dimension questionnaire (EQ-5D-5L) will be used to evaluate generic health-related quality of life for caregivers. The scores range from less than 0 to 1.0, with higher scores representing higher health utility.

  Baseline and three-month post-intervention

Secondary Outcomes (24)

• Change from baseline in patients' unscheduled health service visits due to heart-related problems at immediately post-intervention

  Baseline and post-intervention immediately

• Change from baseline in patients' unscheduled health service visits due to heart-related problems at three-month post-intervention

  Baseline and three-month post-intervention

• Change from baseline in patients' CHF self-care behavior at immediately post-intervention

  Baseline and post-intervention immediately

• Change from baseline in patients' CHF self-care behavior at immediately post-intervention

  Baseline and three-month post-intervention

• Change from baseline in patients' smoking status at immediately post-intervention

  Baseline and post-intervention immediately

Study Arms (2)

ACT Group

EXPERIMENTAL

The ACT intervention was structured to take place over one month on a weekly basis via Tencent's VooV platform. Each roughly 2-hour session will consist of a group-based ACT (1.5 hours) and a brief health education talk on CHF self-management (0.5 hours). Each training session will serve about 4-8 dyads. In addition, each participant will receive one set of session handouts on CHF education, ACT skills, and a homework assignment.

Behavioral: ACT (Acceptance and Commitment Therapy) plus brief CHF education

HE group

ACTIVE COMPARATOR

The participants of the control group will receive four weekly 2-hour sessions of structured health education on CHF self-management over four consecutive weeks via Tencent's VooV platform, delivered by a registered nurse. Each session will includea a review of the previous session (except the first session), a CHF education talk and a Q\&A section to evaluate the participant's understanding of the key concepts. Each session will be offered to 4-8 patient-caregiver dyads. In addition, each participant will receive session handouts on the main topic related to CHF self-management and homework assignments.

Behavioral: HE (Health Education)

Interventions

ACT (Acceptance and Commitment Therapy) plus brief CHF education BEHAVIORAL

The participants will identify their values and clarify their alternative behavior, exploring their thoughts and feelings, and finding ways to meet their own and their family member's needs. The rational bond between the patient and his/her family caregiver will be emphasized. In addtion, the contents of brief CHF education are based on the latest national clinical practice guideline for CHF, including symptoms monitoring, medication adherence, fluid and salt restriction, smoking cessation, alcohol consumption, and physical activity maintenance.

ACT Group

HE (Health Education) BEHAVIORAL

The educational contents are based on the latest national clinical practice guideline for CHF. Besides the basic information on CHF education provided in intervention group, the contents of CHF education also include definition of CHF, epidemiology, diagnosis, comorbidity, and CHF treatment. ACT components are not covered.

HE group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• a confirmed diagnosis of Chronic Heart Failure (CHF) according to international guidelines
• with New York Heart Association (NYHA) functional classification I to III
• has been hospitalized in the past one year
• able to nominate a primary family caregiver (if two or more family members where the primary caregivers of the patient, the one who had the highest average contact hours with the patient)
• can understand and communicate in Chinese
• can access Tencent VooV Meeting via smartphone for attending the intervention

You may not qualify if:

• has a documented medical history of psychiatric illness, dementia, and life-threatening, such as end-stage renal failure, severe pulmonary disease and respiratory disease
• has cognitive impairment evaluated with a score of 0-2 on the Mini-Cog scale
• living in a nursing home
• Caregiver
• years or older
• can understand and communicate in Chinese
• have been providing care to the patient for more than 14 hours per week for at least three consecutive months
• can access Tencent VooV Meeting via smartphone for attending the intervention
• paid caregivers
• has a documented medical history of psychiatric illness, dementia, and life-threatening, such as end-stage renal failure, severe pulmonary disease and respiratory disease
• has cognitive impairment evaluated with a score of 0-2 on the Mini-Cog scale

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

Taihe Hospital

Shiyan, Hubei, 430000, China

Location

Related Publications (1)

• Zhang X, Ho GWK, Mak YW. Effectiveness of a videoconferencing group-based dyad acceptance and commitment therapy on the quality of life of chronic heart failure patients and their family caregivers: A study protocol for a randomized controlled trial. PLoS One. 2024 Apr 18;19(4):e0298178. doi: 10.1371/journal.pone.0298178. eCollection 2024.

  PMID: 38635558 DERIVED

MeSH Terms

Interventions

Helium

Intervention Hierarchy (Ancestors)

Noble Gases; Elements; Inorganic Chemicals; Gases

Study Officials

• Yim Wah Mak, PhD

  School of Nursing, The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 8, 2021
• Study Start: June 10, 2022
• Primary Completion: September 14, 2023
• Study Completion: September 14, 2023
• Last Updated: August 29, 2024

Record last verified: 2022-05

Locations

CN (1)